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enzalutamide

Trade name: xtandi

Small moleculeapprovedFast Track FDA

Approved

Aug 31, 2012

Enzalutamide (brand name Xtandi) is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. It was developed at UCLA and marketed by the pharmaceutical company Medivation for the treatment of metastatic castration-resistant prostate cancer. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate specific antigen (PSA) level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance. — NCATS

Clinical trial activity

296 trials · 218 clinical orgs · 11 marketing orgs

Phase 1
89
Phase 2
214
Phase 3
53
Phase 4
12

Earliest trial started Sep 1, 2005 (NCT00268476)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Medivation — Earliest Phase 1 Sponsor(trial)

  3. Feb 1, 2007

    Medivation — IND Organization

  4. Feb 1, 2007

    Medivation — IND Organization

  5. Jan 1, 2009

    Medivation — Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 31, 2012

    Medivation — Earliest FDA Approval

  2. Aug 31, 2012

    Medivation — NDA Organization

  3. Aug 31, 2012

    Astellas — NDA Secondary Org

2020s

  1. Aug 4, 2020

    Leo Pharma — NDA Secondary Org

  2. May 14, 2021

    Actavis — Marketing Organization

  3. May 14, 2021

    AbbVie — Marketing Organization

  4. Apr 22, 2022

    Apotex — Marketing Organization

  5. Aug 2, 2022

    Sandoz — Marketing Organization

  6. Aug 2, 2022

    Novartis — Marketing Organization

  7. Sep 26, 2024

    Zydus Discovery DMCC — Marketing Organization

  8. Jun 24, 2025

    Government of China — Marketing Organization

  9. Feb 2, 2026

    Hikma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackAug 31, 2012

Chemistry & pharmacology

Loading structure…

SMILES

CNC(=O)C1=C(F)C=C(C=C1)N2C(=S)N(C(=O)C2(C)C)C3=CC(=C(C=C3)C#N)C(F)(F)F
Mol. weight
464.436 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • enzalutamide
  • ezalutamide
  • mdv3100
  • mdv3100
  • mdv3100
  • mdv3100
  • mdv 3100
  • mdv-3100
  • mdv-3100
  • mdv-3100
  • mdv-3100
  • xtandi
  • xtandi
  • xtandi
  • xtandi
  • xtandi

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07287150Phase 2Mar 31, 2026Roche
NCT07311694Phase 3Jan 31, 2026Hengrui Therapeutics, Inc.
NCT07241416Phase 3Dec 31, 2025Hengrui Therapeutics, Inc.
NCT07226986Phase 1/Phase 2 (Phase 2)Dec 16, 2025Novartis
NCT07277270Phase 1/Phase 2 (Phase 2)Dec 8, 2025GlaxoSmithKline
NCT07230106Phase 2Nov 30, 2025Hengrui Therapeutics, Inc.
NCT07104110Phase 1/Phase 2 (Phase 2)Oct 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT07198633Phase 1/Phase 2 (Phase 2)Oct 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT07028853Phase 3Sep 28, 2025Pfizer
NCT06894511Phase 2Sep 11, 2025Novartis
NCT07104643Phase 1/Phase 2 (Phase 2)Aug 31, 2025TYK Medicines, Inc
NCT06922318Phase 2Aug 19, 2025Johns Hopkins University, National Cancer Institute (NCI), Zenith Epigenetics
NCT06991556Phase 2Jul 7, 2025Novartis
NCT06863272Phase 1/Phase 2 (Phase 2)Jun 17, 2025Daiichi Sankyo, Merck
NCT06844383Phase 2Apr 30, 2025Harvard University, Memorial Sloan-Kettering Cancer Center, Pfizer, Prostate Cancer Clinical Trials Consortium
NCT05726292Phase 2Apr 1, 2025University of Chicago
NCT06764485Phase 3Mar 13, 2025Bristol-Myers Squibb, Celgene
NCT06691984Phase 3Jan 31, 2025Amgen
NCT06592924Phase 3Jan 15, 2025Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI), NRG Oncology, SWOG Cancer Research Network
NCT06576037Phase 1Dec 31, 2024University of Texas at Houston
Showing 20 of 296 trials
Page 1 / 15

Organizations

Research & Development (218)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstellasFor profit813252009
MedivationFor profit531452007
National Cancer Institute (NCI)Government341042013
PfizerFor profit20832007
MerckFor profit12842016
BayerFor profit11542013
Johns Hopkins UniversityAcademic/Hospital111022014
Harvard UniversityAcademic/Hospital9632013
Cornell UniversityAcademic/Hospital7532013
AstraZenecaFor profit6542017
National Comprehensive Cancer NetworkAcademic/Hospital6032013
NovartisFor profit6332014
University of LondonAcademic/Hospital6522014
University of Texas at HoustonAcademic/Hospital6622013
Cancer Trials IrelandAcademic/Hospital5222014
Department of DefenseGovernment5012015
Oregon Health and Science UniversityAcademic/Hospital5332014
University of California, San FranciscoAcademic/Hospital5412015
University of Colorado, DenverAcademic/Hospital5532015
Zenith EpigeneticsFor profit5322016
218 organizations
Page 1 / 11

Marketing (14)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGMay 14, 2021
ActavisFor profitMKTGMay 14, 2021
ApotexFor profitMKTGApr 22, 2022
AstellasFor profitNDA2Aug 31, 2012
Government of ChinaGovernmentMKTGJun 24, 2025
HikmaFor profitMKTGFeb 2, 2026
Leo PharmaFor profitNDA2Aug 4, 2020
MedivationFor profitNDAAug 31, 2012
MedivationFor profitINDFeb 1, 2007
NovartisFor profitMKTGAug 2, 2022
SandozFor profitMKTGAug 2, 2022
SandozFor profitSYNApr 20, 2026
Zydus Discovery DMCCFor profitMKTGSep 26, 2024
Zydus Discovery DMCCFor profitSYNSep 30, 2024